Trelstar

DRUG DESCRIPTION

TRELSTAR (triptorelin pamoate for injectable suspension) is a white to slightly yellow lyophilized cake. When reconstituted, TRELSTAR (triptorelin pamoate for injectable suspension) has a milky appearance. It contains a pamoate salt of triptorelin, a synthetic decapeptide agonist analog of gonadotropin releasing hormone (GnRH). The chemical name of triptorelin pamoate is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-tryptophyl-L-leucyl-L-arginyl-L-prolylglycine amide (pamoate salt). The empirical formula is C64H82N18O13 C23H16O6 and the molecular weight is 1699.9. The structural formula is:

TRELSTAR (triptorelin pamoate) Structural Formula Illustration

The TRELSTAR (triptorelin pamoate for injectable suspension) products are sterile, lyophilized biodegradable microgranule formulations supplied as single dose vials. Refer to Table 5 for the composition of each TRELSTAR (triptorelin pamoate for injectable suspension) product.

Table 5. TRELSTAR (triptorelin pamoate for injectable suspension) Composition

Ingredients TRELSTAR 3.75 mg TRELSTAR 11.25 mg TRELSTAR 22.5 mg
triptorelin pamoate (base units) 3.75 mg 11.25 mg 22.5 mg
poly-d,l-lactide-co-glycolide 136 mg 118 mg 182 mg
mannitol, USP 69 mg 76 mg 68 mg
carboxymethylcellulose sodium, USP 24 mg 27 mg 24 mg
polysorbate 80, NF 1.6 mg 1.8 mg 1.6 mg

When 2 mL sterile water is added to the vial containing TRELSTAR (triptorelin pamoate for injectable suspension) and mixed, a suspension is formed which is intended as an intramuscular injection. TRELSTAR (triptorelin pamoate for injectable suspension) is available in two packaging configurations: (a) TRELSTAR (triptorelin pamoate for injectable suspension) vial alone or (b) TRELSTAR (triptorelin pamoate for injectable suspension) vial plus a MIXJECT vial adapter, and a separate pre-filled syringe that contains sterile water for injection, USP, 2 mL, pH 6 to 8.5.

What are the precautions when taking triptorelin pamoate for injectable suspension (Trelstar)?

Before taking this product, tell your doctor or pharmacist if you are allergic to either olmesartan, amlodipine, or hydrochlorothiazide; or to other angiotensin receptor blockers (such as losartan); or to ACE inhibitors (such as lisinopril); or to other calcium channel blockers (such as nifedipine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease (such as renal artery stenosis, anuria), loss of too much body water (dehydration), liver disease, gout, lupus, untreated mineral imbalance (such as high/low potassium, low magnesium, high...

Read All Potential Precautions of Trelstar


Trelstar Consumer (continued)

SIDE EFFECTS: Dizziness, lightheadedness, tiredness, or headache may occur as your body adjusts to the medication. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

The hydrochlorothiazide in this product may cause a loss of too much body water (dehydration) and salt/minerals. Tell your doctor immediately if you have any of these unlikely but serious symptoms of dehydration or mineral loss: very dry mouth, extreme thirst, muscle cramps, weakness, fast/irregular heartbeat, nausea/vomiting, severe dizziness, confusion, fainting, seizures.

Tell your doctor immediately if any of these unlikely but serious side effects occur: toe/joint pain, swelling hands/ankles/feet.

Tell your doctor immediately if any of these rare but serious side effect occurs: unusual change in the amount of urine (not including the normal increase in urine when you first start this drug), decrease in vision, eye pain.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking this product, tell your doctor or pharmacist if you are allergic to either olmesartan, amlodipine, or hydrochlorothiazide; or to other angiotensin receptor blockers (such as losartan); or to ACE inhibitors (such as lisinopril); or to other calcium channel blockers (such as nifedipine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease (such as renal artery stenosis, anuria), loss of too much body water (dehydration), liver disease, gout, lupus, untreated mineral imbalance (such as high/low potassium, low magnesium, high calcium), heart valve disorder (such as aortic stenosis).

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

If you have diabetes, this product may affect your blood sugar levels. Check your blood sugar levels regularly as directed by your doctor. Tell your doctor immediately if you have symptoms of high blood sugar such as increased thirst and urination. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This product may increase or decrease the potassium levels in your blood. Before using potassium supplements or salt substitutes that contain potassium, consult your doctor or pharmacist.

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

Too much sweating, diarrhea, or vomiting may increase your risk of lightheadedness. Report prolonged diarrhea or vomiting to your doctor.

Older adults may be more sensitive to the effects of this product, especially dizziness.

This medication is not recommended for use during pregnancy due to the risk for harm to an unborn baby. Consult your doctor for more details. (See also Warning section.)

It is unknown if amlodipine or olmesartan passes into breast milk. Hydrochlorothiazide passes into breast milk. Consult your doctor before breast-feeding.



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